Enterococcus Screening Medium

• 2 recalls, same reason

  • Terminated Z-0474-2016 FDA Class II ·initiated 29 Jun 2015
  • Terminated Z-0473-2016 FDA Class II ·initiated 29 Jun 2015

  The affected expired lots of product may have exhibited breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 29212 near the end of shelf life. The in-date product may also exhibit breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 29212 near the end of shelf life.

• • Terminated Z-2628-2014 FDA Class II ·initiated 28 Jul 2014

  These lots of Agar may have exhibited breakthrough growth of vancomycin susceptible Enterococcus species control organisms. Agar that allows susceptible enterococci to grow appears as a falsely resistant culture. If a lab does not QC, the error would be identified as falsely resistant enterococci would have further AST workup. There could be a delay in the identification of false-resistance

• • Terminated Z-1798-2013 FDA Class II ·initiated 6 Jun 2013

  Microbiological identification media may exhibit reduced levels of Vancomycin.

510(k) Number

K951539 ↗

FDA Product Code

JWY

Device Class

Class II

Regulation

21 CFR Part 866.1640

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Gcii Agar with Isovitalx(R) Enrichment

  Class II

  FDA 510(k) K945569 Active Cleared 2 Feb 1995

• Fosfomycin, 200 Mg, Sensi-Disc

  Class II

  FDA 510(k) K972098 Active Cleared 28 Jul 1997

• Meropenem, 10 Mcg, Sensi-Disc Open recall

  Class II

  FDA 510(k) K963845 Active Cleared 25 Oct 1996

• Sparflozacin, 5 Mcg, Sensi-Disc

  Class II

  FDA 510(k) K970385 Active Cleared 10 Mar 1997

• Crystal Enteric/Nonfermenter Id System

  Class I

  FDA 510(k) K926018 Active Cleared 11 Mar 1993

• Gc II Agar with Isovitalex

  Class II

  FDA 510(k) K932882 Active Cleared 24 Sep 1993

See all devices from Becton Dickinson Microbiology Systems →